Executive Director, Medical Safety Assessment Therapeutic Lead, Neuroscience
Bristol Myers Squibb
12 days ago
Remote friendly (Madison, NJ)
United States
Medical Affairs
Responsibilities:
- Provide strategic oversight and delivery of medical safety assessment by managing a safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair product/TA Safety Management Team (SMT).
- Oversee/review/approve aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of clinical trial documents and regulatory filings.
- Lead evaluation and management of safety signals from any data source; guide signal evaluation strategy and ensure documentation/communication.
- Approve safety labeling activities and provide safety subject-matter expertise for regulatory labeling.
- Oversee global safety strategy in development; support submission document production and review final summary documents.
- Develop/execute benefit-risk management and safety risk language; ensure safety review of DSUR/annual reports and periodic safety submissions.
- Oversee lifecycle safety strategy for marketed products; approve DSUR/PBRER and renewal/postmarketing submissions; oversee risk management plan (RMP) execution.
- Lead postmarketing signal evaluation and regulatory responses; guide postmarketing safety studies with other groups.
- Drive process change, support inspections readiness, manage issue/crisis management, liaise to maintain a collaborative patient safety team, and hire/mentor staff.
Qualifications/Required:
- MD/equivalent.
Preferred:
- Postgraduate qualification/experience in internal medicine, immunology, oncology, or related specialty.
- 7+ years in pharmacovigilance or relevant medical/pharma field; management experience strongly preferred.
Key Skills/Competencies:
- Deep drug development and PV knowledge; regulatory safety assessment expertise; analytical reasoning; ability to manage multiple complex projects; attention to detail; strong written/verbal communication; lead in matrix environments.
Benefits (explicitly listed):
- Health coverage; wellbeing programs; 401(k), disability/life/accident insurance and other financial protections.
- Paid time off (flexible time off or annual vacation/holidays by location) and additional time-off/leaves based on eligibility.
Travel: Occasional US and overseas travel.
- Provide strategic oversight and delivery of medical safety assessment by managing a safety physician team.
- Oversee safety activities and benefit-risk strategies for assigned compounds/programs; chair product/TA Safety Management Team (SMT).
- Oversee/review/approve aggregate safety review documents (e.g., DSUR, PBRER) and safety sections of clinical trial documents and regulatory filings.
- Lead evaluation and management of safety signals from any data source; guide signal evaluation strategy and ensure documentation/communication.
- Approve safety labeling activities and provide safety subject-matter expertise for regulatory labeling.
- Oversee global safety strategy in development; support submission document production and review final summary documents.
- Develop/execute benefit-risk management and safety risk language; ensure safety review of DSUR/annual reports and periodic safety submissions.
- Oversee lifecycle safety strategy for marketed products; approve DSUR/PBRER and renewal/postmarketing submissions; oversee risk management plan (RMP) execution.
- Lead postmarketing signal evaluation and regulatory responses; guide postmarketing safety studies with other groups.
- Drive process change, support inspections readiness, manage issue/crisis management, liaise to maintain a collaborative patient safety team, and hire/mentor staff.
Qualifications/Required:
- MD/equivalent.
Preferred:
- Postgraduate qualification/experience in internal medicine, immunology, oncology, or related specialty.
- 7+ years in pharmacovigilance or relevant medical/pharma field; management experience strongly preferred.
Key Skills/Competencies:
- Deep drug development and PV knowledge; regulatory safety assessment expertise; analytical reasoning; ability to manage multiple complex projects; attention to detail; strong written/verbal communication; lead in matrix environments.
Benefits (explicitly listed):
- Health coverage; wellbeing programs; 401(k), disability/life/accident insurance and other financial protections.
- Paid time off (flexible time off or annual vacation/holidays by location) and additional time-off/leaves based on eligibility.
Travel: Occasional US and overseas travel.